Biological Samples. If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.
Biological Samples. If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee biological samples (e.g., blood, urine, tissue, saliva, etc.) obtained from Trial Subjects for testing that is not directly related to patient care or safety monitoring, including pharmacokinetic, pharmacogenomic, or biomarker testing (“Biological Samples”). a.
Biological Samples. If so specified in the Protocol and the informed consent document, Principal Investigator may collect and provide to CRO, Pfizer or their designee biological samples obtained from Study Subjects (e.g., blood, urine, tissue, saliva, etc) for testing that is not directly related to Study Subject care or safety monitoring, such as pharmacokinetic, pharmacogenomic, or biomarker testing (“Biological Samples”). 11.2
Biological Samples. “Biological Samples” means blood, fluid and/or tissue samples collected from Trial Subjects as may be set forth in the Protocol, and tangible materials directly or indirectly derived from such samples. Institution and Investigator will collect, retain and/or use Biological Samples solely as set forth in the Protocol. Institution and/or Investigator will provide Sponsor with quantities of Biological Samples as required by the Protocol. Sponsor may use such Biological Samples as specified in the Protocol, and as permitted in the Consent Documents and by Applicable Law. 8.3
Biological Samples. If so specified in the Protocol, Institution may collect and provide to Sponsor or its designee biological samples (e.g., blood, urine, tissue, saliva, etc.) obtained from Trial Subjects for testing that is not directly related to patient care or safety monitoring, including pharmacokinetic, pharmacogenomic, or biomarker testing (“Biological Samples”). 11.2 Vzorky biologického materiálu. Pokiaľ je uvedené v protokole inštitúcia môže zhromaždiť a odovzdať zadávateľovi alebo ním poverenému zástupcovi vzorky biologického materiálu (napr. vzorky krvi, moču, tkanív, slín atď.) odobraté subjektom skúšania na účely testovania, ktoré nesúvisí priamo so starostlivosťou o pacienta alebo bezpečnostným monitorovaním vrátane testovania farmakokinetických a farmakogenomických vlastností a biomarkerov (ďalej len „vzorky biologického materiálu“).
Biological Samples. If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee blood, fluid and/or tissue samples collected from Trial Subjects (“Biological Samples”). All Biological Samples shall be the sole property of Sponsor. 12.2
Biological Samples. 2.9.1 Institution/Principal Investigator shall use all samples derived from Study subjects enrolled in the Study, including blood, bone marrow, sera, platelets and other biological materials in accordance with the Protocol and the Study subject informed consent.
Biological Samples. If so specified in the Protocol and the informed consent document, Principal Investigator may collect and provide to CRO, Sponsor or their designee, biological samples obtained from trial subjects (e.g., blood, urine, tissue, saliva, etc) for testing that is not directly related to trial subject care or safety monitoring, such as pharmacokinetic, pharmacogenomic, or biomarker testing (“Biological Samples”). Biological Samples may include Personal Data (as defined elsewhere herein) of trial subjects of which the processing is governed by the applicable legislation in the territory of the Slovak Republic. For the avoidance of doubt, the Contracting Parties explicitly confirm, that the restriction of processing Personal Data of trial subjects exclusively in pseudonymized form, as indicated in Appendix 2, Art. 10.5, shall apply in full extent also to Biological Samples of trial subjects. a.
Biological Samples. It is expected that the Institution will, from time to time, transfer Biological Samples to the Sponsor. The Parties agree that any such transfer of Biological Samples shall be subject to the following terms and conditions. The Biological Samples shall be transmitted to the Sponsor at the Sponsor’s expense and shall be de-identified. The Biological Samples shall be used only for the purposes of the Study and shall under no circumstances be administered to human subjects. The Biological Samples shall not be used, analysed or modified other than necessary for the purposes of the Study and as consented to in the Study Participant’s Informed Consent Form. The Sponsor shall handle and store the Biological Samples in accordance with Applicable Laws and as specified in the Protocol (if applicable). The Sponsor shall not attempt to identify or contact the Study Participants from whom the Biological Samples were collected, or to compromise or otherwise infringe the confidentiality of information of the Study Participants. Upon completion of the Study, after testing as required by the Protocol, or after the end of the storage period stipulated in the Protocol and/or Informed Consent Form (if applicable), the Sponsor shall discontinue its use of the Biological Samples and shall, at its risk and expense, completely destroy all remaining Biological Samples in its possession in accordance with Applicable Laws and the instructions of the Institution (if any). A written confirmation of such disposal / destruction shall be provided to the Institution upon request. The Institution and Principal Investigator make no warranties, express or implied, concerning the Biological Samples, and in particular the merchantability or fitness for a particular purpose of the Biological Samples. The Institution and Principal Investigator shall not be liable for any direct, consequential or other damages suffered by the Sponsor or others as a result of or in connection with the Study or the provision or use of the Biological Samples. In witness hereof, the Parties have caused this Agreement to be executed as of respective dates written below. Signed on behalf of the Sponsor Signature : Name : Designation : Date : In the presence of: Signature : Name : Designation Date : : Signed on behalf of the Institution Signature : Name : Designation : Date : In the presence of: Signature : Name : Designation Date : : The Principal Investigator acknowledges this Agreement and understands the obligations...
Biological Samples. If so specified in the Protocol, Institution may collect and provide to Sponsor or its designee Biological Samples. a.
